Metabolic Response Evaluation of Low-sugar Snack Bars

Obesity Clinical Trial

Official title:

Metabolic Response Evaluation of Low-sugar Snack Bars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653220
• Other study ID #: 2019/00861
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: May 26, 2023

Study information

• Verified date: August 2023
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the post-prandial metabolic response and biomarker response, following the consumption of newly developed low glycaemic index (GI) snack bars. The snack bars are formulated with different combinations and ratios of ingredients and food structures. The low sugar products maintaining glucose homeostasis and preventing metabolic problems may have commercial potential as a novel functional ingredient in a variety of fields, including nutrition, medicine, and agriculture.

Description:

In this study we will study and compare the postprandial metabolic response of 5 snack bar variants, 1 control product and 2 glucose (25g) reference drinks. The study will have a total of 8 test sessions in a non-blinded, crossover design. Online computer software will be used for simple randomization of the sequence of the 8 treatments (http://www.randomizer.org/).The 5 snack bars variants will be similar in macronutrient composition but will differ in the source of carbohydrate, fibre and protein (rice, bamboo, inulin, soy, promitor). They will be compared to a visually similar control product (crokao) that is higher in sugar. The reference drink will be anhydrous glucose (25g) dissolved in 250 ml of water.Study population: 15-20 participants will be recruited from each of the following ethnicities: Chinese, Indian and Caucasian. During the screening session, participants will receive an informed consent form and given ample time to go through it and rectify any queries they have with the researcher. The number of test sessions will be discussed between the researcher and the participants, depending on the volunteer's schedule. If they decide to take part in the study, they will be asked to sign the informed consent form. They will then be asked to complete a screening questionnaire and subsequently baseline measurements including anthropometric measurements, blood pressure, and fasting blood glucose will be collected from each participant in order to determine their eligibility. The screening questionnaire will include demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Anthropometric measurements: Body weight and body composition will be measured using bioelectrical impedance analysis (Tanita scale). Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage and hip circumference will be measured at the maximum protuberance of the buttocks. Blood pressure will be measured using an Omron blood pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is measured. Measurements will be taken in duplicate and the averaged results will be recorded.

Study protocol: The day before a test day, participants will be encouraged to consume their usual diet and avoid alcohol consumption and participating in vigorous exercise. On test days, participants will arrive at the laboratory after an overnight fast of 10 h. Upon arrival, participants will be asked to void, and have their weight and body fat assessed with a Tanita scale. After that, participants will enter the clinical suit and rest for 15 min before a blood catheter is inserted in the antecubital vein of the arm. After the blood catheter is inserted, participants will rest for 15 min, before two baseline blood sample (6 mL) are taken 10 minutes apart (-10 min and 0 min). Immediately after the second sample, participants will be served a test food that has to be consumed within 15 min. Subsequently blood samples (6mL) are obtained at 15, 30, 45, 60, 90,120, 180 and 240min. Appetite sensations (e.g. hunger, fullness, desire-to-eat etc.) will also be measured using questionnaires at similar time points when blood samples are taken. Subjects will be asked to rate their appetite sensations on a 100 mm visual analogue scale (VAS). After each session, the blood catheter will be removed. The participants will leave the laboratory and they will be asked to keep a food diary of what they eat for the remaining day. Participants will return until all test foods are consumed. During the entire test session, the subject will have to stay rested and in the laboratory. Television and a workspace will be provided to the subject.Blood samples will be will analysed for METABOLIC RESPONSE (glucose, insulin, Triglycerides, NEFA, GLP-1 and ghrelin). A 100 uL aliquot of blood during the first blood sample collection (T = -10min) will be obtained from each participant on the first day of treatment (thus only once) for baseline metabolomics profiling.A stool sample from each participant will be obtained to perform the following on the microbiome: DNA extraction, library prep, 16S and shotgun (whole genome) sequencing, and demultiplexing of genomic data. The stool sample will be collected between the screening session and the last test session (time of collection will not influence the sample analysis). The participant will be encouraged to collect the stool sample during one of the sessions at the research centre to eliminate transport of the sample.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male

• Age between 21-65 years

• Chinese, Indian and Caucasian Ethnicity

• Body mass index between 18.5 - 25.5 kg/m2

• Fasting blood glucose <7.0 mmol/L

• Normal blood pressure (<140/90 mmHg)

• In general good health

Exclusion Criteria:

• Smoking

• Partake in sports at a high competitive and/or endurance levels

• Intentionally restrict food intakeHave known glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Have poor veins impeding venous access and have any history of severe vasovagal syncope (blackouts or near faints) following blood draws

• Have metabolic diseases (such as diabetes, hypertension, etc.)

• have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)

• Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug,

• Have any severe food allergy or food intolerance

• Having active Tuberculosis (TB) or currently receiving treatment for TB

• Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)

• Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted

• Concurrent participation in a study that might affect the outcomes of the current study

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Obesity
• Pre Diabetes
• Prediabetic State

Intervention

Other:
• Control 1
25g glucose dissolve in 250ml of water
• Control 2
25g glucose dissolve in 250ml of water
• Standard Crokao
Standard Crokao containing 25g of available carbohydrate
• Low sugar variant 1
Low sugar variant 1 containing 25g of available carbohydrate
• Low sugar variant 2
Low sugar variant 2 containing 25g of available carbohydrate
• Low sugar variant 3
Low sugar variant 3 containing 25g of available carbohydrate
• Low sugar variant 4
Low sugar variant 4 containing 25g of available carbohydrate
• Low sugar variant 5
Low sugar variant 5 containing 25g of available carbohydrate

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postprandial blood glucose over 240 minutes period	Venous Blood obtained through canula, analysed using Beckman Coulter analyser.	240 minutes
Secondary	Change in postprandial plasma insulin over 240 minutes period	Venous blood obtain through cannula, analysed using Beckman Coulter analyser.	240 minutes
Secondary	Change in postprandial plasma triglycerides over 240 minutes period	Venous blood obtain through cannula, analysed using Beckman Coulter analyser.	240 minutes
Secondary	Change in postprandial plasma non esterified fatty acids over 240 minutes period	Venous blood obtain through cannula, analysed using chemistry analyser.	240 minutes
Secondary	Change in postprandial plasma active ghrelin over 240 minutes period	Venous blood obtain through cannula, analysed using ELISA analyser.	240 minutes
Secondary	Change in postprandial plasma active GLP-1 over 240 minutes period	Venous blood obtain through cannula, analysed using ELISA analyser.	240 minutes